TY - JOUR
T1 - Budesonide and the risk of pneumonia
T2 - a meta-analysis of individual patient data
AU - Sin, Don D.
AU - Tashkin, Donald
AU - Zhang, Xuekui
AU - Radner, Finn
AU - Sjöbring, Ulf
AU - Thorén, Anders
AU - Calverley, Peter MA
AU - Rennard, Stephen I.
PY - 2009/9/4
Y1 - 2009/9/4
N2 - Background: Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids. We aimed to establish the effects of inhaled budesonide on the risk of pneumonia in such patients. Methods: We pooled patient data from seven large clinical trials of inhaled budesonide (320-1280 μg/day), with or without formoterol, versus control regimen (placebo or formoterol alone) in patients with stable COPD and at least 6 months of follow-up. The primary analysis compared treatment groups for the risk of pneumonia as an adverse event or serious adverse event during the trial or within 15 days of the trial end. Cox proportional hazards regression was used to analyse the data on an intention-to-treat basis. Data were adjusted for patients' age, sex, smoking status, body-mass index, and postbronchodilator percent of predicted forced expiratory volume in 1 s (FEV1). Findings: We analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment. We recorded no significant difference between treatment groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio 1·05, 95% CI 0·81-1·37) or a serious adverse event (1% [n=53] vs 2% [n=50]; 0·92, 0·62-1·35), or for time to pneumonia as an adverse event (log-rank test 0·94) or a serious adverse event (0·61). Increasing age and decreasing percent of predicted FEV1 were the only two variables that were significantly associated with occurrence of pneumonia as an adverse event or a serious adverse event. Interpretation: Budesonide treatment for 12 months does not increase the risk of pneumonia in patients with COPD during that time and therefore is safe for clinical use in such patients. Funding: Michael Smith Foundation for Health Research.
AB - Background: Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids. We aimed to establish the effects of inhaled budesonide on the risk of pneumonia in such patients. Methods: We pooled patient data from seven large clinical trials of inhaled budesonide (320-1280 μg/day), with or without formoterol, versus control regimen (placebo or formoterol alone) in patients with stable COPD and at least 6 months of follow-up. The primary analysis compared treatment groups for the risk of pneumonia as an adverse event or serious adverse event during the trial or within 15 days of the trial end. Cox proportional hazards regression was used to analyse the data on an intention-to-treat basis. Data were adjusted for patients' age, sex, smoking status, body-mass index, and postbronchodilator percent of predicted forced expiratory volume in 1 s (FEV1). Findings: We analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment. We recorded no significant difference between treatment groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio 1·05, 95% CI 0·81-1·37) or a serious adverse event (1% [n=53] vs 2% [n=50]; 0·92, 0·62-1·35), or for time to pneumonia as an adverse event (log-rank test 0·94) or a serious adverse event (0·61). Increasing age and decreasing percent of predicted FEV1 were the only two variables that were significantly associated with occurrence of pneumonia as an adverse event or a serious adverse event. Interpretation: Budesonide treatment for 12 months does not increase the risk of pneumonia in patients with COPD during that time and therefore is safe for clinical use in such patients. Funding: Michael Smith Foundation for Health Research.
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U2 - 10.1016/S0140-6736(09)61250-2
DO - 10.1016/S0140-6736(09)61250-2
M3 - Article
C2 - 19716963
AN - SCOPUS:69149110944
VL - 374
SP - 712
EP - 719
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9691
ER -